Menu
Peptide Database
Results
No peptides found
Featured

Use search to browse all 100+ peptides

PT-141

Bremelanotide, Vyleesi

Quick Stats
Studies 74
Trials 10
Recruiting PHASE4 INTERVENTIONAL NCT06867835

Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The primary objectives of this clinical trial performed with Vyleesi (Bremelanotide Injection) are: * to evaluate if Bremelanotide (BMT) is secreted in breast milk of lactating women treated with a single dose of BMT 1.75 mg SC. * to measure the concentration and characterize the pharmacokinetics of BMT secreted in breast milk of lactating women treated with a single dose of BMT 1.75 mg SC. This open-label, pharmacokinetic (PK) study will be performed in 10 healthy lactating female subjects between 10 days and 6 months post-partum (inclusive). The maximum duration of subject participation in the study will be approximately 29 days, consisting of 3-week Screening period, a 1 day treatment period, and up to a 7 day follow-up period.

Interventions

Name: Vyleesi (Bremelanotide Injection)
Type: DRUG
Description: Single dose of BMT 1.75 mg SC on Day 1

Primary Outcomes

Measure: Levels of Bremelanotide (BMT) in Breast Milk Over 24h After Administration of Vyleesi
TimeFrame: 24 hours
Description: The levels/concentrations of bremelanotide (BMT) will be measured in breast milk samples collected at different timepoints up to 24h from lactating women who receive a single dose of Vyleesi (BMT 1.75 mg SC).
Measure: Area under the curve from time 0 to end of dosing interval (AUCtau) for BMT in Breast Milk
TimeFrame: 24 hours
Description:
Measure: Maximum observed concentration (Cmax) of BMT in breast milk
TimeFrame: 24 hours
Description:
Measure: Time to reach Cmax of BMT in breast milk (Tmax)
TimeFrame: 24 hours
Description:
Measure: Terminal half-life of BMT in breast milk (t1/2)
TimeFrame: 24 hours
Description:

Trial Information

NCT ID

NCT06867835

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE4

Sponsor

Cosette Pharmaceuticals, Inc.

Last Updated

December 15, 2025